Device for the treatment of macular degeneration and other eye disorders

ABSTRACT

Introduced is a device that may be used to treat the effects of macular degeneration and other eye disorders by increasing the optical effect of the retinal surface of the eye. This may be accomplished using a device whose body has a shape prescribed to increase the depth of the fovea and, in the process, make the sides of the clivus more convex, thereby utilizing the varying optical properties of the retinal area. A suitable association of this device with the eye will cause an image beam traveling from the lens through the vitreous humor to magnify and impinge an image perception area encompassing the macula. According to one advantageous embodiment, the device includes a body adapted for association with the eye to manipulate the retina of the eye to effectively augment the photoreceptor cells proximate the macula of the eye. The body of the device may be that of a band, a segment, a partial band, a plate, or, for that matter, any shape suitably adapted to perform the functions described herein to treat the effects of macular degeneration as well as other eye disorders.

CROSS REFERENCE TO RELATED PATENT DOCUMENTS

This application is a continuation of prior U.S. application Ser. No.09/185,155 filed on Nov. 3, 1998 now U.S. Pat. No. 6,146,366.

The present disclosure is related to the inventions disclosed in thefollowing United States patent applications and issued United Statespatents:

(1) U.S. patent application Ser. No. 08/463,749 entitled “TREATMENT OFPRESBYOPIA AND OTHER EYE DISORDERS” and filed Jun. 5, 1995;

(2) U.S. patent application Ser. No. 08/946,975 entitled “SCLERALPROSTHESIS FOR TREATMENT OF PRESBYOPIA AND OTHER EYE DISORDERS” andfiled Oct. 8, 1997;

(3) U.S. patent application Ser. No. 09/032,830 entitled “SEGMENTEDSCLERAL BAND FOR TREATMENT OF PRESBYOPIA AND OTHER EYE DISORDERS” andfiled Mar. 2, 1998;

(4) U.S. patent application Ser. No. 09/061,168 entitled “SCLERALPROSTHESIS FOR TREATMENT OF PRESBYOPIA AND OTHER EYE DISORDERS” andfiled Apr. 16, 1998;

(5) U.S. Pat. No. 5,465,737 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Nov. 14, 1995;

(6) U.S. Pat. No. 5,489,299 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Feb. 6, 1996;

(7) U.S. Pat. No. 5,503,165 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Apr. 2, 1996;

(8) U.S. Pat. No. 5,529,076 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Jun. 25, 1996;

(9) U.S. Pat. No. 5,354,331 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Oct. 11, 1994; and

(10) U.S. Pat. No. 5,722,952 entitled “TREATMENT OF PRESBYOPIA AND OTHEREYE DISORDERS” and issued on Mar. 3, 1998;

which are commonly owned by the assignee of the present invention. Thedisclosures of these related United States patent applications andissued United States patents (collectively referred to hereafter as the“Presbyopia and Related Eye Disorder Patent Documents”) are incorporatedherein by reference for all purposes as if fully set forth herein.

TECHNICAL FIELD OF THE INVENTION

The present invention is generally related to the treatment of eyedisorders and, more particularly, to device for the treatment of maculardegeneration.

BACKGROUND OF THE INVENTION

Macular degeneration is a degenerative (age related) process thatinvolves a highly specialized central part of the retina of the eyeknown as the macula, which is responsible for detailed central visiontasks such as reading, television viewing, sewing, etc. The various riskfactors that may play a role in the cause of macular degeneration arebeing acutely studied—heredity, nutritional deficiencies,arteriosclerosis and hypertension, smoking, exposure to ultravioletlight, etc., are all suspect but further research is necessary toclearly identify the most significant factors.

Signs and symptoms of macular degeneration are gradual blurring ordistortion of central vision interfering with basic functions, such asreading and other like activities. It is not at all uncommon toexperience some loss of central visual function as a natural consequenceof aging, although many individuals suffer more significant and evendrastic loss of central vision.

In many early cases, vision may not be noticeably affected and thecondition is discovered during a routine medical eye examination asthere is a typical appearance to the macula which alerts theophthalmologist to the problem. Tiny yellowish deposits of degenerativematerial are often noticed in the macular area as well as alterations inthe normal structure and pigmentation of the macula. Glasses will notcorrect the poor vision caused by macular degeneration.

While some people experience only minor inconvenience from masculardegeneration and are able to compensate and lead normal lives, manyothers with more severe forms of macular degeneration may beincapacitated. Conventional treatment, including surgical procedures aswell as therapeutic treatments, such as those employing systemicinjection of a drug candidate, have had mixed results, and, in certaininstances, have caused deleterious side effects. A need therefore existsfor a treatment that reduces or limits the effects of maculardegeneration.

SUMMARY OF THE INVENTION

To address the above-discussed deficiencies of the prior art, it is aprimary object of the present invention to introduce a device that maybe used through a surgical process to treat the effects of certain eyedisorders, particularly macular degeneration. As introduced hereinabove,symptoms of macular degeneration include gradual blurring or distortionof central vision functions. Typically, tiny yellowish deposits ofdegenerative material called “drusen” appear in the macular area (orcentral retina), as well as alterations in the normal structure andpigmentation of the macula. Ultimately the macula area is destroyed.

In accordance with the principles of the present invention, introducedis a device that treats the effects of macular degeneration and othereye disorders by manipulating the optical effect of the retinal surfaceof the eye. According to one advantageous embodiment, this isaccomplished using a device comprising a body that may be employed toincrease the depth of the fovea and, in the process, to make the sidesof the clivus more convex, thereby utilizing the varying opticalproperties of the retinal area to increase the optical effect of thesame. In short, a suitable association of this device with the eye willcause an image beam traveling from the lens of the eye through thevitreous humor to magnify and impinge an image perception area that isrelatively larger than the macula and preferably encompasses the same.

According to one advantageous embodiment, the device includes a bodyadapted for association with the eye, having a shape prescribed tomanipulate the retina of the eye to effectively augment thephotoreceptor cells proximate the macula. The prescribed shape of thebody of the device is that of a band, a segment, a partial band, aplate, or, for that matter, any shape suitably adapted to perform thefunctions described or referenced herein to treat the effects of maculardegeneration as well as other eye disorders. In point of fact, such bodymay likewise have any suitable geometric dimension and physical shape,including circular, round, rectangular, triangular, quadrilateral,conical, or other like form, or suitable combination of two or more ofthe same.

In a related embodiment, the device is comprised of a plurality ofsegments, each having a body with a prescribed shape that enables thesegments to cooperatively manipulate the retina of the eye. Again, thismanipulation augments the photoreceptor cells proximate the macula ofthe eye to form an increased image perception area that preferablyencompasses the macula. According to a preferred embodiment, two or moresegments may suitably be in physical association with one another, and,in alternate or related embodiments, two or more cooperating segmentsmay not be physically associated. Nevertheless, such segments may formany one or more of a band, a combined segment, a partial band, a plate,or, again, any other shape suitably adapted to perform the functionsdescribed herein.

In short, a primary aspect of the device embodiments introduced here,and described in greater detail below, is their common capability tomanipulate the optical effect of the retinal surface of the eye to treatcertain eye disorders. This manipulation may directly, or indirectly,(i) increase the depth of the fovea; (ii) make the sides of the clivusmore convex to more fully utilize the varying optical properties of theretinal area; (iii) augment the photoreceptor cells proximate the maculaof the eye to form an increased image perception area; (iv) alter theeffective focal distance between the lens and the retinal area; or (v)some combination of two or more off the same.

The foregoing Summary of the Invention outlines, rather broadly, someadvantageous features of various embodiments of the present invention sothat those of ordinary skill in the art may better understand theDetailed Description that follows. Additional features of the inventionwill be described hereafter that form the subject matter of the Claimsof the Invention. Those of ordinary skill in the art should appreciatethat they can readily use the disclosed conception and specificembodiments as a basis for designing or modifying other structures forcarrying out the same purposes of the present invention. Those ofordinary skill in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentinvention in its broadest form.

Lastly, before undertaking the Brief Description of the Drawings and theDetailed Description, it may be advantageous to set forth severaldefinitions (in addition to those already provided) for certain wordsand phrases used throughout this patent document, as follows: the terms“include” and “comprise,” as well as derivatives thereof, mean inclusionwithout limitation, and may be used interchangeably; the term “or,” isinclusive, meaning and/or; and the phrases “associated with” and“associated therewith,” as well as derivatives thereof, may mean toinclude, be included within, interconnect with, contain, be containedwithin, connect to or with, couple to or with, be communicable with,cooperate with, interleave, be a property of, be bound to or with, have,have a property of, or the like. Definitions for certain words andphrases are provided throughout this patent document, and suchdefinitions apply to prior, as well as future uses of such defined wordsand phrases.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawings wherein like numbers represent like, or analogous,objects and, in which:

FIG. 1a illustrates a two-dimensional cross-sectional representation ofan exemplary human eye;

FIG. 1b illustrates a more detailed two-dimensional cross-sectionalrepresentation of the macula area of a human eye;

FIG. 2 illustrates a two-dimensional cross-sectional representation ofan association of a plurality of segments according to the presentinvention with an eye for cooperatively treating the effects of maculardegeneration;

FIG. 3 illustrates a plan view of a segment embodiment of a deviceaccording to the principles of the present invention;

FIG. 4 illustrates a front elevational view of the segment embodiment ofFIG. 3;

FIG. 5 illustrates a side view of the segment embodiment of FIGS. 3 and4;

FIG. 6 illustrates a plan view of an exemplary segment embodiment of adevice according to the principles of the present invention;

FIG. 7 illustrates a plan view of an exemplary partial band embodimentof a device according to the principles of the present invention;

FIG. 8 illustrates a plan view of a plurality of associated segmentsthat cooperate to form a band embodiment of a device according to theprinciples of the present invention;

FIG. 9 illustrates a plan view of a plurality of disassociated segmentsthat cooperate to form a band embodiment of a device according to theprinciples of the present invention;

FIG. 10 illustrates a round/circular shaped body of a device having asolid core; and

FIG. 11 illustrates a round/circular shaped body of a device having aliquid/gel filled cavity.

DETAILED DESCRIPTION

Turning initially to FIG. 1a, illustrated is a two-dimensionalcross-sectional representation of an exemplary human eye (generallydesignated 100) that details the basic anatomy of the same. For thepurposes of illustrating the principles of the present invention, it isbeneficial to describe the structure and function of a few parts of theeye 100, namely, the sclera 105, the conjunctiva 110, the cornea 115,the iris 120, the pupil 125, the crystalline lens 130, the ciliary body135, the retina 140, the macula 145, the optic nerve 150, and thevitreous humor (generally designated 155).

The sclera 105 is the “white of the eye,” which is a tough protectivecoat consisting of collagen and elastic tissues. The outermost layer ofthe sclera 105, called the episclera, is a thin filmy substance withnumerous blood vessels. Scleral thickness varies at different pointsranging from the thinnest portion (approximately 0.3 millimeters) nearthe muscle insertions to the thickest (approximately 1.0 to 1millimeters) at the back of the eye. The conjunctiva 110 is the “skin”of the eye, which is a thin, filmy, transparent membrane covering thesclera 105. The conjunctiva 110 also lines the inner side of the eyelidsand contains numerous blood vessels and some mucus and tear glands.

The cornea 115 is the clear, transparent “window” of the eye. The cornea115 is approximately 12 millimeters in diameter and typically variesfrom a little more than one half millimeter in thickness centrally to alittle less than a millimeter at the edges. The cornea 115 consists offive distinct layers (from front to back): epithelium, Bowman'smembrane, stroma, Descemet's membrane, and endothelium. The cornea 115contains numerous tiny nerve fibers, but no blood vessels. The iris 120is the “colored part of the eye” (e.g., blue, brown, green, hazel,etc.). The iris 120 contains two major sets of muscles (for dilating andconstricting the pupil) and numerous blood vessels and pigment cells andgranules. The pupil 125 is the black “hole” or “space” in the center ofthe iris 120. The pupil 125 is not actually a structure or component ofthe eye 100, but an empty space, like an “open window.”

The crystalline lens 130, along in cooperation with the cornea 115,provides for the focusing of light rays entering the eye 100. The lens130, consisting of regularly oriented protein fibers surrounded by aclear capsule, is a biconvex disc suspended in place by the zonulesconnecting it to the ciliary body 135. The curvature of the lens 130 maybe altered or changed, providing variable focus power to the eye 100.The ciliary body 135, along with the iris 120 and the choroid isconsidered part of the uveal tract or uvea of the eye. The ciliary body135 contains numerous blood vessels and various muscles for focusing theeye 100, as well as the pigment cells and granules found in other partsof the uvea. The ciliary body 135 also serves as the point of attachmentfor the zonules or suspensory ligaments of the lens 130 and contains thecells that operate to secrete the aqueous humor found in the anteriorand posterior chambers.

The retina 140 is the nerve cell layer of the eye 100 that functionsmuch like the film in a camera. In short, the remainder of the eye 100serves to focus light on to the retina 140 where photochemical reactionsoccur as part of the process of vision. The retina 140 is a thin,transparent tissue containing some 120 million separate rod cells (nightvision) and 7 million cone cells (day and color vision) as well asmillions of other structural supporting and interconnecting cells(collectively, the photoreceptor cells). The macula 145 is thesensitive, central, part of the retina that provides for sharp, detailedvision and contains the highest concentration of color-sensitive conecells. The fovea (not shown) is the center of the macula 145. Theretinal blood-vessels course through the retinal substance and, alongwith the underlying choroid (the richly vascular, pigmented tissuesituated between the retina 140 and the sclera 105), supply thenecessary nutrients and oxygen for normal retinal function. These bloodvessels are remote branches of the large carotid arteries in the neckand can become occluded by fragments of calcium and cholesterol whichchip off from partially blocked carotid arteries and flow into the eye100.

The optic nerve 150 is the main “trunk line,” consisting of a million orso separate nerve fibers, conducting nervous impulses from the retina140 to the brain (not shown). The optic nerve 150 exits at the back ofthe eye 100 and joins with the optic nerve 150 of the fellow eye at theoptic chiasm (not shown). The vitreous humor 155 is a gel-like fluidthat occupies the large space bounded by the lens 130 and ciliary body135 in front and the retina 140 and optic nerve 150 in the back of theeye 100. The vitreous humor 155 serves a cushioning and protectivefunction for the eye 100 and is normally optically clear. The vitreoushumor 155 consists of collagen, mucopolysaccharides and hyaluronic acidin a delicate balance.

Turning next to FIG. 1b, illustrated is a more detailed two-dimensionalcross-sectional representation of the macula area (generally designated145) of a human eye, and, more particularly, the retinal tissue area 160(which includes the nerve fiber layer, ganglion cells and the connectingcells of FIG. 1a), the photoreceptor cells 165, the fovea 170, and theclivus 175. The fovea 170 is a shallow rounded “pit” lying about 4 mm.to the temporal side of the optic disc and about 0.8 mm. below thehorizontal meridian (noting that such distance varies, occasionally evenbetween the two eyes). The depression is due to the practicaldisappearance of the inner layers of the retina, which is partlycompensated by an increased thickness of the bacillary layer. The shapeof the fovea 170 is that of a “shallow bowl” with a concave floor. Thesides form a curving slope known as the clivus 175 descending from thefoveal margin which, incidentally, is the thickest part of the retina.In the center of the “shallow bowl” is a slight dip, the foveola (or“little fovea,” not shown) in the midst of which is a small centralconcavity, the umbo (or “navel,” not shown). The photoreceptor cells 165in the region of the floor of the fovea 170 are more cones and areclosely packed, longer and more tenuous than in other regions of theretina. As the rods are eliminated and the cones are aggregated andslenderized, the threshold of stimulation of the area tends to rise.

Turning now to FIG. 2, illustrated is a two-dimensional cross-sectionalrepresentation of an exemplary association of a plurality of segments200 a to 200 n with exemplary eye 100 according to the principles of thepresent invention for cooperatively treating the effects of maculardegeneration. As will be discussed in greater detail hereinbelow,segments 200 a to 200 n cooperatively manipulate the retina 140 toaugment the photoreceptor cells 165 proximate the macula 145 to form anincreased image perception area 205 that preferably encompasses themacula 145.

It should be noted that the prescribed shape of the segments 200 isillustrative only and introduced as a shape adapted to augment thephotoreceptor cells 165, and, more particularly, although the bodies ofthe segments 200 are shown as rectangular, alternate advantageousdimensions and physical shapes may suitably include circular/round (seeexpansion box), triangular, quadrilateral, conical, or other likephysical form, or combination of the same.

Exemplary rays of light 210 pass through the cornea 115 and the pupil120, intersecting the lens 130, which begins the process of focusing bybending (refracting) the light rays 210. The lens 130 converges thelight rays 210 into a beam 215 intercepting the macula 145 and impingingupon the retinal area—the macula 145 represents a focal point for thelens 130. The lens 130 therefore operates to refine the light rays 210into narrower beams to provide clearer images. Thus, after focusing bythe lens 130, the light beam 210 travels through the transparentvitreous humor 155 and impinges the retina 140.

Turning to the expansion box, the retinal area (previously designated205) contains hundreds of millions of specialized nerve cells arrangedin complex patterns. The photoreceptor cells (or “vision receivers”) 165are of two types, namely, rods and cones. The rods outnumber the conesand function best under conditions of low illumination. The conesprovide detailed vision and color vision. The heaviest concentration ofcone cells in the retina is in the macula 145. The macula 145 includesthe fovea 170, an area of extremely sensitive cone cells responsible fordiscerning fine detail vision. The fovea 170 is damaged as a result ofmacular degeneration.

Besides the photoreceptor cells 165, the retina 145 includes many othertypes of connecting and supporting cells within the retinal tissue, suchas the retinal pigment epithelium (not shown) which absorbs excess lightand provides a nutritive function for the retina 140. More particularly,the clivus 175 is illustrated as “thickenings” of the visual-cell, outernuclear, inner nuclear, ganglion-cell, and nerve-fiber layers that addup to a local thickening of the retinal area as a whole. An importantaspect of the optical properties of the eye is the effect that thevarying physical properties of the vitreous humor 155, the retinaltissue, and the photoreceptor cells 165. In short, the vitreous humor155 is largely transparent, the retinal tissue is, in part, reflective,and the photoreceptor cells 165 are light absorbent.

According to the present embodiment, each segment 200 is, as introducedhereinabove, capable of increasing the depth of the fovea 170 and, inthe process, making the sides of the clivus 175 more convex. Byincreasing the convexity of the sides of the clivus 175, the segments200 a to 200 n take advantage of and more fully utilize the varyingoptical properties of the retinal area, and, in particular, the fovea170 and the clivus 175, to increase the optical effect of the same. Asis illustrated by the retinal area expansion box, the illustratedassociation of the device segments 200 a to 200 n with the eyeeffectively manipulate the retinal area to augment the photoreceptorcells 165 proximate the macula 145.

In short, image beam 215 travels from the lens 130 through the vitreoushumor 155 to magnify and impinge a larger image perception area 205relative to macula 145. The image beam 215 is refracted by theincreasingly convex sides of clivus 175 causing the image beam 215 to bespread across a greater number of photoreceptor cells 165. Theelectrical impulses that are generated by the interaction of the lightbeam 215 with the photoreceptor cells 165 are transmitted to the opticnerve, which consists of a myriad fibers. The optic nerves from each eyeexit the eyeball and join each other at the base of the brain at pointcalled optic chiasm (not shown). At the optic chiasm a complex crossingof nerve fibers occurs and the visual impulses are then passed to theoptic tracts which end in the lateral geniculate bodies. From there,visual impulses pass along the optic radiations which terminate in theoccipital cortex at the back of the brain. In this area, there areextremely complex interconnections and visual association areas. It isat this point in the process where vision, as we know it, is perceived.

Note that the fovea 170 (in particular, and the retinal tissue,generally) has a relatively higher refractive index than that of thevitreous humor. Therefore, any part of the light beam 215 that strikesthe “vitreoretinal” boundary at other than a right angle will refractaway from an imaginary perpendicular and “disperse” down to thephotoreceptor cells 165. Association of the segments 200 with the eyecooperatively manipulate the retina 140, augmenting the photoreceptorcells 165 proximate the macula 145 to increase the foveal depression todeliberately take advantage of this refraction. The manipulated retinalarea causes the formation of an increased image perception area 205; inother words, the foveal portion of the retinal image is expanded on itsway through the retinal tissue, and is purposefully magnified when itreaches the level of the photoreceptor cells 165. The increase in thedepth of the fovea 170 therefore directly affects visual acuity. Inpoint of fact, the deeper the actual depression proximate the originallevel of the retina, the higher the mound or ‘circumfoveal eminence’created around the depression by the displaced tissue of the clivus 175.The continuous steep slope produced from the crest of the mound to thebottom of the depression becomes an effective magnifying device, ofoptically unique description.

Again, the segments 200 a to 200 n, and shapes thereof, are by way ofillustration only, and in no means should there use be interpreted as alimitation as to the shape, size, number, or any other physicalattributes of the device of the present invention. As will be describedbelow, alternate embodiments of the present invention may suitablyinclude prescribed shapes such as a band, a segment, a partial band, aplate, or, for that matter, any shape suitably adapted to perform thefunctions described in this patent document, as well as combinations ofthe same, to treat the effects of eye disorders, such as maculardegeneration.

A suitable exemplary procedure for associating the device with the eyemight include opening the conjunctiva 110 in the inferior temporalregion-between the lateral and inferior rectus muscles approximately 6mm posterior to the limbus. The sclera 105 is cleaned of Tenon's capsuleand the dissection is carried posterior to the equator of the eye. Apartial thickness scleral incision is made in the sclera 105 to create ascleral pocket that may advantageously extend around or under the macula145 and the fovea 170, such as the types of scleral pocket disclosed inthe Presbyopia and Related Eye Disorder Patent Documents. The device issuitably associated with the eye (such as implanting, suturing, orinserting the same into) via the scleral pocket. The position of thedevice may be verified by indirect or direct ophthalmoscope. The scleralpocket and the conjunctival incisions are closed with standardophthalmic sutures. It should be noted that any suitable medicalprocedure may be undertaken to associate the device with the eye. Therelative effectiveness of various procedures may be based, at least inpart, upon the size, shape, etc. of the device used.

Turning to FIG. 3, illustrated is a plan view of a segment embodiment200 of a device according to the principles of the present invention.For the purposes of illustration, concurrent reference is occasionallymade to the exemplary cross-sectional views of the eye of FIGS. 1a, 1 band 2. The exemplary segment body includes a base 302 with an anterioredge 304, a posterior edge 306, and lateral ends 308 and 310, allcollectively forming a perimeter for an inner surface 312. The exemplaryinner surface 312 includes a ridge 314 illustratively extending alongthe length of the base 302.

According to this embodiment, the segment 200 may be associated with aneye to increase the depth of the fovea 170 and, in the process, to makethe sides of the clivus 175 more convex as described hereinabove,thereby utilizing the varying optical properties of the retinal area 205to increase the optical effect of the same. In short, a suitableassociation of this device 200 with the eye 100 will cause an image beamto magnify and impinge an image perception area 205 that is relativelylarger than the macula 145.

The exemplary segment body has a prescribed shape, in part due toexemplary ridge 314, that is capable of exert a force on the eye 100,that modifies the shape of the eye 100 to suitably manipulate theretinal area 215 and, possibly, to alter the distance between the lens130 and the retina 140. Advantageously, the segment body has the innersurface 312 and an outer surface (not shown) that are separatedsufficiently, again, in part via exemplary ridge 314, to suitably modifythe shape of the eye by exerting the force with respect to the eye 100.

Turning momentarily to FIG. 4, illustrated is a front elevational viewof the segment embodiment of FIG. 3. The segment 200 illustrates thebase 302, lateral ends 308 and 310, and the ridge 314, along with a flatouter surface 400. Turning next to FIG. 5, illustrated is a side view ofthe segment embodiment of FIGS. 3 and 4. The segment 200 illustrates theridge 314, the outer surface 316, and a notch 500 on the inner surface312 of the device, or prosthesis.

A device in accordance with the principles of the present invention maybe made of any suitable material that is sufficiently rigid to exert aforce when associated with the eye to manipulate the optical effect ofthe retinal surface thereof. The device is preferably physiologicallyacceptable for long-term implantation or contact with the oculartissues. Such materials are known in the art and include suitable metals(e.g., titanium, gold, platinum, stainless steel, tantalum, varioussurgically acceptable alloys, etc.), ceramics (e.g., crystalline andvitreous materials such as porcelain, alumina, silica, silicon carbide,high-strength glass, etc.), and synthetic resins (e.g., physiologicallyinert materials such as polymethyl methacrylate, polyethylene,polypropylene, polytetrafluoroethylene, polycarbonate, silicone resins,etc.). The device may also be made of composite materials incorporatinga synthetic resin or other matrix reinforced with fibers of highstrength material such as glass fibers, boron fibers or the like (e.g.,glass-fiber-reinforced epoxy resin, carbon fiber-reinforced epoxy resin,carbon fiber-reinforced carbon (carbon-carbon), etc.).

In alternate advantageous embodiments, the device may be made fromorganic materials such as preserved collagen, preserved sclera, and thelike, as well as artificial collagen or the like. In other embodiments,the device may be made of a semi-rigid exterior that forms a cavitywithin the body of the device. The cavity may suitably be empty, or,alternatively, be filled with a liquid, a gel or the like. Thisembodiment may suitably be alterable so that the dimensions of the samecan- be altered by injecting various amounts of air, liquid (e.g.,water, saline, silicone oil, etc.), or gel (e.g., silicone, collagen,gelatin, etc.). Of course, the semi-rigid exterior may be made of anyone or more of the materials set forth or referenced herein. It shouldbe noted that the devices disclosed herein may be associated withmicro-electro-mechanical systems (“MEMS”) and related technologies tosuitably alter or augment one or more of the devices or manipulate useof the same as described herein to increase the optical effect of theretinal surface of the eye.

Turning now to FIG. 6, illustrated is a plan view of an exemplarysegment embodiment 200 of a device according to the principles of thepresent invention. For the purposes of illustration, concurrentreference is occasionally made to the exemplary cross-sectional views ofthe eye of FIGS. 1a, 1 b and 2. The exemplary segment body is curved andincludes an anterior edge 304, a posterior edge 306, and lateral ends308 and 310, all collectively forming a perimeter for an inner surface312. According to this embodiment, the segment 200 may again beassociated (alone or in combination with one or more other suitabledevices) with an eye to increase the depth of the fovea 170 and, in theprocess, providing increased convexity to the sides of the clivus 175 toutilize the varying optical properties of the retinal area 205 toincrease the optical effect of the same. In short, a suitableassociation of this device 200 with the eye 100 will cause an image beamto magnify and impinge an image perception area 205 that is relativelylarger than the macula 145. The exemplary segment body has a prescribedshape capable of exerting a force to the eye 100 once associatedtherewith, that modifies the shape of the eye 100 to manipulate theretinal area 215 and, possibly, to alter the distance between the lens130 and the retina 140. In the present embodiment, the exemplaryprescribed shape is curved, and the curvature is chosen to provide atleast an approximate match for the curvature of the surface of the eye,or, in alternate embodiments (e.g. FIG. 8), the curvature is chosen toprovide at least an approximate match for the curvature of any adjacentdevice bodies also associated with the eye. As will be described withreference to FIGS. 10 and 11, the segment body has the inner surface 312and an outer surface (not shown) that are separated sufficiently tosuitably modify the shape of the eye by exerting the force with respectthereto.

Turning momentarily to FIG. 7, illustrated is a plan view of anexemplary partial band embodiment 200 of a device according to theprinciples of the present invention. The partial band, when suitablyassociated with an eye, has a shape prescribed to increase the depth ofthe fovea 170 and to provide increased convexity to the sides of theclivus 175. Again, this utilizes the varying optical properties of theretinal area to increase the optical effect of the same. In short, thepartial band will cause an image beam traveling from the lens of the eyethrough the vitreous humor to magnify and impinge an image perceptionarea 205 that is relatively larger than the macula. Similarly, FIG. 8illustrates a plan view of a plurality of associated segments 200 a to200 d that cooperate to form a complete band, or “donut,” embodiment 200of a device according to the principles of the present invention. Incontrast, FIG. 9 illustrates a plan view of a plurality of disassociatedsegments 200 a to 200 d that cooperate to form an implicit bandembodiment 200 of a device according to the principles of the presentinvention.

It will also be understood by the skilled practitioner that any of thedevices described herein, as well as equivalent constructions within thespirit and scope of the present invention in its broadest form, maysuitably be associated with the eye, and, in particular, the retinalarea, surgically through a scleral pocket, or belt loop, sutured,stapled, bonded, or otherwise physically associated with the eye tomanipulate the retinal area in accordance with the teachings orreferenced herein. It should also be understood that the material ofwhich any of the foregoing devices, or, for that matter, any device inaccord with the teachings hereof, is made may be adapted to any suitableparticular shape or design chosen therefor.

For instance, FIGS. 10 and 11 illustrate a round/circular shaped body ofdevice 200 respectively having a solid core and a liquid/gel filledcavity 1100. In both illustrations, the device body has a top surface312 and a bottom surface 1000 that are separated sufficiently tosuitably modify the shape of the eye by exerting the force with respectthereto. The filled cavity 1100 may suitably be filled with a liquid, agel or the like to alter dimensions of the device.

Regardless, the devices of the present invention may be manufactured byany conventional or later developed technique appropriate to thematerial used, such as machining, injection molding, heat molding,compression molding and the like. Similarly, the devices hereof may befoldable, made in a plurality of segments, or otherwise manufactured sothat it can be assembled prior to use or may be installed separately toform a complete device.

Although the principles of the present invention have been described indetail, those of ordinary skill in the art should understand that theycan make various changes, substitutions and alterations herein withoutdeparting from the spirit and scope of the invention in its broadestform. For instance, although use of the devices of the present inventionhave been described with reference to treatment of macular degenerationand other like eye disorders in humans, this treatment may also beapplicable to treating various eye disorders suffered by other animals.It should be noted that the Presbyopia and Related Eye Disorder PatentDocuments include descriptions of devices directed to the treatment ofpresbyopia and other like eye disorders.

What is claimed is:
 1. A device to treat the effects of maculardegeneration comprising a body adapted for association with an eye andhaving a shape prescribed to manipulate the retina of the eye toeffectively augment the photoreceptor cells proximate the macula of theeye, wherein said device is made of a physiologically acceptablematerial for long-term association with ocular tissue.
 2. The device asset forth in claim 1 wherein said prescribed shape is one of a band, asegment, a partial band, and a plate.
 3. The device as set forth inclaim 1 wherein said prescribed shape causes said device, whenassociated with the eye, to alter the optical effect of the clivus.
 4. Adevice for association with an eye to treat the effects of maculardegeneration, said device having a shape prescribed to manipulate theretina of the eye to augment the photoreceptor cells proximate themacula of the eye, wherein said device is made of a physiologicallyacceptable material for long-term association with ocular tissue.
 5. Thedevice as set forth in claim 4 wherein said prescribed shape is one of aband, a segment, a partial band, and a plate.
 6. The device as set forthin claim 4 wherein said prescribed shape causes said device, whenassociated with the eye, to alter the optical effect of the clivus. 7.The device as set forth in claim 6 wherein said prescribed shape iscapable of manipulating the retina of the eye to alter the depth of thefovea.
 8. The device as set forth in claim 7 wherein said prescribedshape is capable of manipulating the retina of the eye to alter theconvexity of the clivus, augmenting the photoreceptor cells proximatethe macula the eye, thereby forming an increased image perception areaencompassing the macula to treat the effects of macular degeneration. 9.The device as set forth in claim 4 wherein said device has at least twosurfaces that are sufficiently separated to exert a force with respectto the eye.
 10. The device as set forth in claim 9 wherein said shapecauses said device, when associated with the eye, to exert said forceinwardly with respect to the eye.
 11. The device as set forth in claim 9further adapted for association with a surgically formed pocket withinthe eye whereby said at least two surfaces exert said force inwardlywith respect to the eye.
 12. The device as set forth in claim 4 whereinsaid physiologically acceptable material is selected from at least oneof metals, ceramics, synthetic resins, composite materials, and organicmaterials.
 13. The device as set forth in claim 4 wherein said deviceincludes a cavity.
 14. A plurality of segments for association with aneye to treat the effects of macular degeneration, each of said pluralityof segments having a prescribed shape that enables said plurality ofsegments to cooperatively manipulate the retina of the eye to augmentthe photoreceptor cells proximate the macula of the eye thereby formingan increased image perception area encompassing the macula, wherein atleast one said plurality of segments is made of a physiologicallyacceptable material for long-term association with ocular tissue. 15.The plurality of segments as set forth in claim 14 wherein at least oneof said plurality of segments is capable of being associated with atleast one other of said plurality of segments.
 16. The plurality ofsegments as set forth in claim 14 wherein said plurality of associatedsegments form one of a band, a combined segment, a partial band, and aplate.
 17. The plurality of segments as set forth in claim 14 whereinsaid prescribed shape of each of said plurality of segments is capable,when associated with the eye, of altering the optical effect of theclivus.
 18. The plurality of segments as set forth in claim 17 whereinsaid prescribed shape of each of said plurality of segments is capableof manipulating the retina of the eye to alter the depth of the fovea.19. The plurality of segments as set forth in claim 18 wherein saidprescribed shape of each of said plurality of segments is capable ofmanipulating the retina of the eye to alter the convexity of the clivus,effectively augmenting the photoreceptor cells proximate the macula theeye, thereby forming said increased image perception area encompassingthe macula to treat the effects of macular degeneration.
 20. Theplurality of segments as set forth in claim 14 wherein at least one saidplurality of segments has a body having at least two surfaces that aresufficiently separated to exert a force with respect to the eye.